FDA.reportPublic FDA data

Application 204748

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 150MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52584-814CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-814CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-815CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-815CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-816CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-816CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-816CLINDAMYCINCLINDAMYCINGeneral Injectables and Vaccines, Inc.ANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-814ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-815ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
67457-816ClindamycinClindamycinMylan Institutional LLCANDACurrent
71872-7168ClindamycinClindamycinMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50023ORIG2017-10-12